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Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

NCT ID: NCT02296437

Last Updated: 2017-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tDCS + CT

Group Type EXPERIMENTAL

Transcranial direct current stimulation combined with cognitive training

Intervention Type OTHER

Interventions

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Transcranial direct current stimulation combined with cognitive training

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participants are aged 18-65 years.
2. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
3. MADRS score of 20 or more.
4. Right handed
5. A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

Exclusion Criteria

1. DSM-V psychotic disorder.
2. Drug or alcohol abuse or dependence (preceding 6 months).
3. Inadequate response to ECT (current episode of depression).
4. Regular benzodiazepine medication
5. Rapid clinical response required, e.g., due to high suicide risk.
6. Clinically defined neurological disorder or insult.
7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
8. Pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Melissa Pigot

Research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of New South Wales

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Donel Martin, PhD

Role: CONTACT

Phone: 61 2 9382 8353

Email: [email protected]

Facility Contacts

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Donel Martin, PhD

Role: primary

Other Identifiers

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HC14216

Identifier Type: -

Identifier Source: org_study_id